Electronic medicament inhalers are widely used for the treatment of respiratory diseases such as asthma, COPD, cystic fibrosis, and bronchiectasis. They are also becoming more prevalent for dispensing insulin for people with diabetes.
A common type of medicament inhaler is what is known as a pressurised Metered Dose Inhaler (pMDI). Such inhalers generally comprise a medicament canister and an actuator. The medicament canister contains medicament under pressure and is designed to deliver a metered dose of medicament in the form of an aerosol spray. The actuator generally comprises a substantially L-shaped hollow tube which has a first open end adapted to receive the medicament canister, and a second open end which acts as a mouth piece.
Medicament canisters for use with a pMDI generally have a spray stem extending from one end which is adapted to engage with a spray-directing element housed within the actuator, and adjacent to the mouth piece of the actuator. When the canister is pushed down into the actuator, the spray stem and spray-directing element combine to direct a metered dose of medicament out through the mouthpiece and into the mouth of the user.
Another common type of medicament inhaler is what is known as a Dry Powder Inhaler (DPI). DPI's are generally in the form of a disc or grinder which may be rotated in order to dispense a metered dose of dry powder into an appropriate receptacle or mouthpiece, from where it may then be inhaled by the user (for example, by sucking strongly on the mouthpiece of the inhaler).
Some medicament inhalers are kept on hand for use in a specific event or emergency. For example, if a person were to have a sudden asthma attack, they may reach for a medicament inhaler which contains what is generally known as a “reliever” medicament. A reliever medicament is fast acting and in most cases will relieve (or reduce the severity of) the asthma attack, almost instantaneously.
Other medicament inhalers are designed for regular use in order to prevent an event such as an asthma attack and/or to manage or control a disease such as asthma. Such inhalers are generally known as “preventers” because the regular use of such inhalers serves to prevent (or minimise the likelihood of) an asthma attack. The regular use of preventer medicament by asthma sufferers is generally effective in controlling the disease and/or preventing the vast majority of asthma attacks. Commonly, preventer medicament for asthma sufferers is taken twice a day, usually at a set time in the morning and in the evening.
There are now also available “combination” medicament inhalers which combine both a reliever and preventer medicament, with a view to controlling the respiratory disease (with the preventer medicament), when a patient uses their reliever medicament for symptom alleviation.
Studies have shown that many people demonstrate poor disease management, for example by overusing their reliever medicament. The overuse of a reliever medicament has the potential to reduce the effectiveness of the medicament, which may render the medicament less effective in times of real need, for example during a severe asthma attack.
Moreover, a patient's increased use of reliever medicament over a period of time may be indicative of a pending exacerbation event.
A problem or difficulty associated with the use of preventer (or “combination”) medicament inhalers is poor medicament compliance. That is, many studies have shown that users frequently do not take their medicament at the predetermined or prescribed times and/or in the required amounts. This is a particular problem amongst young children, the elderly, or people of reduced mental capacity.
The consequences of this non-compliance are reduced disease control, lower quality of life, lost productivity, hospitalisation and avoidable deaths.
Furthermore, during clinical trials (for example, to test a new preventer medicament), it is important (for the trial to be accurate and/or successful) that the patients in the trial take their medicament at the prescribed times and/or in the prescribed amounts.
Not only is compliance to preventative medicaments typically low, but it has also been shown that actual compliance by a user is lower than the same user's estimated compliance.
To order to address these problems and difficulties, there are presently available a number of electronic medicament inhalers which include compliance monitoring means.
Most compliance monitoring means include, at the very least, dose counting means. For example, see U.S. Pat. No. 5,544,647 (Jewettt et al), U.S. Pat. No. 6,202,642 (McKinnon et al) and US Patent Publication No. 2005/0028815 (Deaton et al).
Furthermore, some presently available electronic medicament inhalers also include means to record a range of compliance data, in addition to dose counting. For example, McKinnon includes an electronics module to record date and time as well as more comprehensive patient usage information.
U.S. Pat. No. 5,363,842 (Mishelevich et al) describes a device which also monitors patient inhalation data, for example how much air is inhaled through the inhaler and with what time course. The resultant data may be transmitted to a remote location such as a health care professional where the inhalation data can be compared to a standard target envelope, and the success or otherwise of the patient's inhalation may then be signaled back to the patient. Mishelevich also monitors for other patient usage data such as whether the medicament inhaler was shaken prior to use.
The patient usage (or compliance) data gathered by such electronic medicament inhalers may be managed or used in various ways.
For example, Deaton displays the patient usage data on a display which is integrally formed with the device. This has limitations in that the patient usage data is only able to be viewed by the user, whereas it would be of more benefit to have the data viewed and/or monitored by a third party such as a care giver or a medical professional.
Jewett includes both an LCD display for displaying patient usage data on the device, as well as a memory for storing data which may later be downloaded to a printer via a terminal. McKinnon describes a docking station which is adapted to receive the electronic medicament inhaler, and retrieve the patient usage data from the inhaler.
A disadvantage associated with Jewett, Deaton and McKinnon is that the patient usage data is not able to be transmitted wirelessly (preferably to a remote location) and/or in real time. Instead, the patient usage data is only able to be downloaded periodically, and at the sole discretion of the user. There is also no provision for the two-way transmission of data.
An advantage of monitoring patient usage data in real time (or at frequent time intervals) is that the patient usage data is always current, and hence anyone viewing or wishing to have access to the data will feel more comfort knowing this. Furthermore, any potential overuse or underuse of the medicament delivery device may be immediately apparent, and (for example) any appropriate alerts may be made to the patient (or to a third party such as a care giver or medical professional). Real time (or frequent) monitoring may also be able to predict a potential exacerbation event, prior to the event occurring.
An advantage associated with the wireless transmission of data, is that the data may be transferred to a remote monitoring location, for example via a mobile phone network to the internet and/or a network computer system. The remote monitoring location may be, for example, a medical professional whereby the medical professional may continuously monitor patient usage or compliance data.
PCT Patent Application No. PCT/US2008/052869 (Levy et al) describes a sleeve housing (24) which is attachable to an actuator body (12). The sleeve housing includes electronic monitoring apparatus and the device is designed to monitor patient usage data, with a view to being able to predict an exacerbation event before it occurs. To facilitate this, Levy discloses the use of wireless technology to transmit the patient usage data. However, Levy relies on a counting means which requires attachment of a cap 28 to the canister (16) which is adapted to engage with a dose-dispensing sensor (26) during the delivery of a dose of medicament. Hence, Levy requires modifications to the inhaler prior to being able to be used. The fitting of the Levy device to an inhaler may therefore be a fiddly and time consuming operation. Furthermore, any modifications made to an inhaler have the potential to interfere with the medicament delivery ability or effectiveness of the inhaler. The Levy device is also not adapted to be fitted to an inhaler which already has electronic compliance monitoring means.
U.S. Pat. No. 6,958,691 (Anderson et al) describes a device for the delivery of medicament which includes a medicament inhaler with an electronic data management system. The Anderson device includes an integral communicator which provides for two-way wireless communication between the electronic data management system and a network computer system. The communication may be in real time.
However, a disadvantage associated with Anderson is that the wireless communication system is integrally formed within the actuator housing. The cost of incorporating such a wireless communication system into each and every inhaler is significant and hence the cost of such a device may be prohibitive.
Furthermore, because the compliance monitoring device is integrated within the medicament inhaler, it cannot generally be reused for longer than the life of the inhaler. Given that each inhaler typically contains a one month supply of medicament, it is economically and environmentally wasteful to supply and then discard such technology with each month's medication.
Recent advances in modern manufacturing techniques are now making it feasible and cost effective, to mass-produce disposable electronic inhalers. That is, each disposable electronic inhaler may include its own (relatively basic) electronic compliance monitoring means (the minimum monitoring means likely being a dose counter and real time clock to record the date/time of each dose of medicament delivered). Whilst this is of advantage given that more people will be able to afford, or have access to, such compliance monitoring means, the problem remains on how to display and/or transmit the patient usage data gathered.
Having regard to the foregoing, it would therefore be of advantage if there was available a communications device which was able to be fitted to an electronic medicament delivery device, such as an electronic inhaler, and whereby the communications device had the ability to wirelessly transmit data gathered by the electronic medicament delivery device to a desired location.